How to Survive an FDA Inspection


June 2, 2022

A big challenge with all medical device manufacturers is to be compliant with any regulations applicable with their product. In the case of the United States it will include 21 CFR Part 820 which is a set of regulations from the FDA that outlines the current good manufacturing practice (CGMP) requirements that manufacturers must follow with regards to their quality system. Register for this free webinar where Anne Holland, CEO of QA Consulting with 20+ years experience advising medical device companies on regulatory and quality needs, will share some preventative actions that your medical device company can take to minimize the possibility of receiving a 483 which in some cases could result in a product seizure.

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